Structuring and Conducting Risk-Based Internal cGMP Compliance Audits

Why Should You Attend:

There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance inspections (audits). These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success.

And business continues to "shoot itself in the foot", including once highly respected companies. All this affects the Agency's approach to audits and their expectations for companies. They also use GMP compliance audits to drive companies to do much of their work for them. Failure to anticipate, find and correct compliance problems before an FDA site inspection can result in unnecessary 483 Observations, possible Warning Letters, or worst, and a competitive “hit” in the marketplace – all preventable by the effective internal CGMP compliance audit / inspection.

During this session, we will evaluate the chief areas of an FDA CGMP compliance audit to see actual and anticipated changes in emphasis based on this new regulatory climate. This information will be used to add to the FDA’s inspection “model”, to provide a field-tested approach to a company’s internal audit program. QSIT for medical devices and pharmaceutical requirements will be combined to provide an effective, proactive and aggressive / robust internal audit program for any regulated industry. Software, data integrity, and cybersecurity issues. A suggested annual time line will be presented. The “must dos” when a notice is received of a pending FDA inspection.

This webinar can also be a significant part of meeting a company’s annual CGMP training requirement (if properly supplemented and documented).

Areas Covered in the Webinar:

• Basic U.S. FDA's expectations – the CGMPs
• The "target" -- Tougher FDA Expectations / Requirements
• Avoid complacency from past "good" FDA / Notified Body / ISO audits
• Key medical device and pharmaceutical CGMP concerns
• A risk-based phased approach
• FDA “model” CGMP inspections
• Prove / maintain 'in control'
• Fight “entropy”

Frequently Asked Questions:

1. What does the FDA look for in terms of "rework" and "reprocess". When does these terms apply; especially for labeling and packaging?
2. What are the common FDA findings for Device History Records?
3. What is the common inspection plan and recommended frequency for a virtual company?
4. What is the expectation for virtual companies on how they should manage vendor quality systems?
5. For audits focused on Material Review Board (MRB) due to non-conforming material, what does the FDA look for during the audit?
6. For companies who have combination products filed under an NDA, are they audited against 210/211, 820, or both?
7. Can you elaborate on P&PC key issues for verified and validated?
8. Do "rework" and "reprocessing" term apply to visual inspection and re-packaging of drug product or finished goods?

Who Will Benefit:

• Senior and middle management.
• Quality Assurance
• Regulatory Affairs
• R&D
• Engineering
• Staff and Line personnel
• Sales and Marketing
• Operations / Production

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 37 years’ experience in U.S. FDA-regulated industries, 23 as an independent consultant. John has worked with companies from start-up to Fortune 100, worldwide. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, submissions, process / product / equipment including QMS and software validations, ISO 14971 product risk management and human factors files / reports, Design History Files, Technical documentation. He's held positions in Engineering, QA, QAE, RA, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, written numerous chapters for books on validation, conducted workshops and webinars worldwide. John is a graduate of UCLA.

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